Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

FDA recall notice · announced March 8, 2017 · Dr. Reddy's Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Failed dissolution specifications - low dissolution results at S3 stage.

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot # KB60197, Exp 2/18
Quantity: 4404 cartons
Status: Terminated
Products in this recall event:
- Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's L (D-0508-2017)
- Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's (D-0506-2017)
- Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's L (D-0507-2017)
- Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's L (D-0509-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.